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Clinical Trials/NCT01862198
NCT01862198
Completed
Phase 4

Pilot Study on the Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent

Inje University2 sites in 1 country27 target enrollmentSeptember 2011
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ConditionsBile Duct ObstructionDisorder of Bile Duct StentNeoplasms

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Bile Duct Obstruction
Sponsor
Inje University
Enrollment
27
Locations
2
Primary Endpoint
The stent patency rate
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to investigate the feasibility and safety of endoscopic ultrasound-guided biliary drainage with a newly designed hybrid metallic stent.

Detailed Description

Endoscopic ultrasound-guided biliary drainage with a fully covered metallic stent was a safe and effective method in patients with malignant biliary obstructions and had a comparatively long patency duration. Nevertheless, the significant rate of distal stent migration cannot be ignored, suggesting the need for a newly designed metallic stent for endoscopic ultrasound-guided biliary drainage.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
August 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tea Jun Song

Assistant professor

Inje University

Eligibility Criteria

Inclusion Criteria

  • •Age \> 20 years
  • •The presence of an unresectable malignant biliary obstruction
  • •Failed conventional ERCP stenting

Exclusion Criteria

  • •Age \< 20 years
  • •An inability to sedate the patient due to advanced heart or pulmonary diseases
  • •A lack of informed consent

Outcomes

Primary Outcomes

The stent patency rate

Time Frame: Up to 48 weeks

Secondary Outcomes

  • Patients' survival rate(Up to 48 weeks)
  • Complication rate related to the hybrid stents(Up to 48 weeks)

Study Sites (2)

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